ANVISA comes up with a new resolution, RDC 751, effective from March 01, 2023. The Resolution defines the risk classification rules for medical devices, labeling requirements and Instructions For Use (IFU), and the procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices. It revokes RDC no. 185/2001, RDC no.15/2014, and RDC no. 40/2015. Here is the gist of the latest Brazilian regulation.
RDC 751 & Risk Classification Rules
RDC 751 includes 22 rules of Risk Classification as ANNEX I, which are related to non-invasive devices, invasive devices, surgically invasive devices, implantable devices, active therapeutic devices, and Software as Medical Devices (SaMDs). Rule 14 and Rule 16 mention the devices classified in Class IV and Class III, respectively.
The medical devices subject to this Resolution are classified according to the risk they cause to the user’s health, patient, operator, or third parties involved,
I - Class I: low risk
II - Class II: medium risk
III - Class III: high risk
IV – Class IV: maximum risk
New Definitions and Updated Terminologies
The RDC 751 has proposed and updated definitions for the Medical Devices, Software as Medical Device (SaMD), Nanomaterial, Accessories & Brazilian Registration holder.(BRH)
According to the new resolution, the definition ofMedical Deviceis any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material, or other article, intended by the manufacturer to be used, alone or together, in human beings, for any of the following specific medical purposes, and whose main intended action is not achieved by pharmacological, immunological means or metabolic in the human body, but which may be aided in their intended action by such means:
- diagnosis, prevention, monitoring, treatment (or relief) of an illness; disability
- diagnosis, monitoring, treatment, or repair of an injury or
- investigation, replacement, alteration of anatomy or of a process or physiological or pathological state
- support or maintenance of life
- design control or support or
- provision of information through in vitro examination of samples from the human body, including organ and tissue donations
The technical dossier is now implemented for all risk classes and is aligned with the Table of Contents of the IMDRF. Notification (for Class I/II) still does not require the submission of the technical dossier, whereas registration (for Class III/IV) requires the preparation and submission of the technical dossier.
For registration applications, the previous technical report is now replaced by the technical dossier (Table of content format).
All documents to address the technical dossier requirements can be provided in either Portuguese, English, or Spanish (except the ANVISA application forms, labels, and IFUs).
The rationale is expected for any requirements of the technical dossier that do not apply to specific devices.
Instructions For Use (IFU) and Label
Requirements for the information on label and Instructions for Use (IFU) are provided in Chapter VI of this Resolution, which provides information on label and instructions for using devices, label template, model instructions, and Instruction for Use (IFU) in unprinted format.
It is prohibited to make the Instructions for Use (IFU) available exclusively in unprinted format for the following products:
- Equipment for health use that indicates:
- Domestic use in general, including those for use in home care services.
- Operation by laypeople, regardless of the place of use.
- Health materials used by laypeople.
Label Update - Replaced importer with registration holder
IFU Update - Removes technical manager, also replaces importer
Deadline to submit the technical dossier under the new structure:
- Devices modified from notification to registration: 365 days (Feb 29, 2024).
- Devices modified from registration to notification: Correction application within 365 days (Feb 29, 2024).
- For devices that maintained the risk class or changed the risk class, but remained in the same registration route, the new table of content structure is required upon submission of the next modification submission.
- For devices still subject to registration but under a different risk Class, Brazilian Good Manufacturing Practice (BGMP) update may be necessary.
On analyzing the aspects that impact medical device registration, the above changes seem to ease the registration process and seem like a boon for companies based outside Brazil and willing to register their medical devices in the Brazilian market.
To gain in-depth insights on new risk classification rules, consolidation of rules for notification, registration, new definitions and concepts, rules for the documentary repository of medical devices, IMDRF’s table of contents for the technical dossier, updated terminology, the conjugated series of regulation of medical devices in a single RDC and also for an impact assessment on your device registrations or Regulatory services in Brazil and other LATAM countries,consulta proven Regulatory expert. Stay informed. Stay compliant.